Randomized trial of intravaginal gel, intravaginal time release insert, and intracervical gel with prostaglandin e2 for induction of labor

OBJECTIVE: To compare three presentations of proslaglandin (PG) E2 for induction of labor. STUDY DESIGN: 74 women with a medical indication for inpatiem induction oflabor were randomi/ed to receive 3 mg PGE2 intravaginal gel every 4 to (i hrs (group 1). 10 ing time release intravaginal insert with dinoprostone, Cervidil®, every 12 hrs (group 2). or 0.5 nig intracervical dinoprostone, Prepidil® gel, every 6 hrs (group 3) until intravenous oxvtocin was started. Change in Bishop score prior to starting oxytocin and complications (uterine hyperslimulation, decelerations) were compared using AN OVA, t-test, and Fisher's exact test, stratified by paritv. Analvsis was inducted blindly to group assignment. RESULTS: 24 subjects were in group 1. 27 in group 2, and 23 in group 3. Distribution by race: white n = 30 (40%), black n = 39 (53%), other n = 5 (7%); 48 (65%) were nulliparons and 26 (35%) were inultiparous. Induction was started at a gestational age (GA) >36 wks in 95% (n - 70). GA uas determined by a second trimester ultrasound in 73/74 and 9/74 (12%) were VBAC. All three treatment groups effectively improved the Bishop scores in both nnlliparous and inultiparous patients (p < 0.005). In the inultiparous women, treatment (2). (Cervidil®), demonstrated to be the most effective (p 0.036) and laboi was initiated more frequently, not needing augmentation with Pitocin (RR: 0.15; 95% CI (0.04, 0.58); p = 0.001). I'terine hvpcrstimnlation was seen in 2/24 (group 1). 5/27 (group 2). and 2/23 (group 3), (p = 0.53). CONCLUSIONS: The time release intravaginal insert with dinoprostone appears to be a more effective agent to ripen the cervix and induce labor in this pilot RCT. I'terine hyperstiniulation resulting from its use needs to befurther studied.